Doxorubicin and Cisplatin With or Without Paclitaxel in Treating Patients With Locally Advanced, Metastatic, and/or Relapsed Endometrial Cancer

European Organisation for Research and Treatment of Cancer (EORTC)

Status and phase

Completed

Phase 2

Conditions

Endometrial Cancer

Treatments

Drug: doxorubicin hydrochloride

Drug: cisplatin

Drug: paclitaxel

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT00052312

EORTC-55984

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether doxorubicin and cisplatin are more effective with or without paclitaxel in treating endometrial cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of combining doxorubicin and cisplatin with or without paclitaxel in treating patients who have locally advanced, metastatic, and/or relapsed endometrial cancer.

Full description

OBJECTIVES:

Compare the overall survival of patients with locally advanced, metastatic, and/or relapsed endometrial cancer treated with doxorubicin and cisplatin with or without paclitaxel.
Compare the toxicity of these regimens in these patients.
Compare the progression-free survival at 18 months of patients treated with these regimens.
Compare quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to performance status (0 vs 1 vs 2), metastatic disease (M0 vs M1), prior pelvic radiotherapy for pelvic recurrence (yes vs no), and participating center. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive doxorubicin IV over 30 minutes, paclitaxel IV over 3 hours, and cisplatin IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Arm II: Patients receive doxorubicin and cisplatin as in arm I. Quality of life is assessed at baseline, before each course, after courses 3 and 6, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. In the event of progressive disease, quality of life is assessed every 3 months.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. In the event of progressive disease, patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 140 patients will be accrued for this study.

Enrollment

141 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Histologically confirmed endometrial epithelial carcinoma meeting at least 1 of the following criteria:
- Advanced metastatic and/or relapsed disease
- Locally advanced inoperable or unresectable disease
No mixed mesodermal tumor and/or tumors showing evidence of sarcomatous elements
Uterine papillary serous carcinoma allowed

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

WHO 0-2

Life expectancy

Not specified

Hematopoietic

Neutrophil count greater than 1,500/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin greater than 10 g/dL (transfusions allowed)

Hepatic

ALT and AST less than 2 times upper limit of normal (ULN)
Alkaline phosphatase less than 2 times ULN
Bilirubin less than 1.5 times ULN

Renal

Creatinine less than 1.5 times ULN
Creatinine clearance greater than 50 mL/min

Cardiovascular

Normal baseline EKG
Normal baseline LVEF on MUGA or echocardiogram for patients who received prior anthracyclines

Other

Able to tolerate high-dose dexamethasone
Must be considered fit for chemotherapy
No uncontrolled infection
No other malignancy within the past 5 years except successfully treated basal cell skin cancer or carcinoma in situ of the cervix
No prior nervous or psychiatric disorder that would preclude study compliance
No psychological, familial, sociological, or geographic condition that would preclude study participation
Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy